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NCT07708025CompletedPhase 3

Oral Iron for the Management of Iron Deficiency Anemia in SGLT2i-Treated Heart Failure Patients

Oral Iron for the Management of Iron Deficiency Anemia in SGLT2i-Treated Heart Failure Patients: A Prospective Analysis

Source: ClinicalTrials.gov · Last updated 16 Jul 2026

Brief summary (registry, in English)

People with heart failure often have anemia caused by low iron levels. Ongoing inflammation in heart failure can impair iron absorption, making oral iron therapy less effective. Sodium-glucose co-transporter 2 inhibitors (SGLT2i) are medications used to treat heart failure. In addition to their cardiovascular benefits, these drugs may improve iron metabolism and support red blood cell production. This study evaluates whether patients with heart failure and iron deficiency anemia who are receiving SGLT2i therapy respond to treatment with oral iron. Participants receive oral iron for three to four months, followed by a short period without treatment. Blood tests are used to assess changes in hemoglobin levels. The objective of this study is to determine whether treatment with SGLT2i enhances the response to oral iron in patients with heart failure and iron deficiency anemia.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
55 (actual)
First submitted
13 Apr 2026
Start date
20 Sept 2025
Primary completion date
26 Feb 2026
Lead sponsor
Universidade do Porto
NCT number
NCT07708025

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 55
  • From 20 Sept 2025 to the primary completion date, 26 Feb 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 1\) Concomitant use of intravenous iron, erythropoiesis-stimulating agents (ESAs), red blood cell transfusions, or other blood products within 3 months before enrollment;
  • 3\) Relevant intercurrent illnesses associated with inflammatory response (e.g., infection, acute kidney injury, or acute decompensated heart failure) within 3 months before enrollment;
  • 5\) End-stage renal disease or receiving renal replacement therapy;

Other illness

  • 4\) Confirmed or suspected active bleeding;
  • 6\) History of any type of active cancer;
  • 7\) History of solid or non-solid organ transplantation.

Lab values

  • 2\) Severe anemia, defined as hemoglobin \<7 g/dL or clinical indication for transfusion;

Who the study is looking for

  • 1\) Previous diagnosis of heart failure, irrespective of ejection fraction;
  • 2\) Iron deficiency anemia defined as hemoglobin \<13 g/dL in men or \<12 g/dL in women, with transferrin saturation (TSAT) \<20%;
  • 3\) Ongoing treatment with an SGLT2 inhibitor (SGLT2i) for more than 3 months at the time of enrollment.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Unidade Local de Saúde São João
Coordinator of this site? Confirm its status
PortoPortugalUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.